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510(k) Data Aggregation
(179 days)
Hunan Vathin Medical Instrument Co., Ltd.
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope has been designed to be used with the Vathin display unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in patients.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope is a single-use device designed for use in adults, with the BCV1-02 and BCV1-C2 also designed for pediatric use (BCV1-02: 6 months to 6 years; BCV1-C2: 6 years and older).
The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScopeTM Single use flexible Video Bronchoscope (model: BCV1-02, BCV1-C2) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenterTM Digital Video Monitor (model: DVM-B1, DVM-B2) for clinical image processing.
The Vathin®H-SteriScopeTM Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCentereTM Digital Video Monitor provides power and processes the images for medical electronic endoscope.
Vathin®H-SteriScopeTM Single-use flexible Video Bronchoscope is a sterile single-use flexible bronchoscope. Vathin®H-SteriScopeTM Digital Video Monitor is a reusable monitor.
I regret to inform you that the provided FDA 510(k) clearance letter and accompanying 510(k) Summary for the Vathin® Video Bronchoscope System do not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving device performance as it relates to AI/software functionality.
This document focuses on justifying Substantial Equivalence for a bronchoscope system based on its physical characteristics, safety standards (electrical, biocompatibility, sterilization), and basic performance (optical, mechanical). It mentions "Software verification and validation" in Section 7.4, citing the "FDA guidance: Content of Premarket Submissions for Device Software Functions," but does not provide any specific acceptance criteria, study data, or details about the software's functionality, especially regarding AI capabilities.
Therefore, I cannot populate the table or answer the specific questions about AI performance, test set details, ground truth establishment, or human reader studies.
Here's why the document is insufficient for your request:
- No AI/Algorithm Claims: The document describes a video bronchoscope and its display unit. It doesn't mention any AI or advanced algorithmic functions (e.g., automated lesion detection, image enhancement using AI, diagnostic support) that would necessitate performance criteria like sensitivity, specificity, or reader studies.
- Focus on Hardware/System Performance: The performance data section (7.1-7.6) primarily addresses the physical and electrical safety, biocompatibility, sterilization, and basic optical/mechanical functions of a medical device (bronchoscope). The "Software verification and validation" entry is generic and doesn't detail any specific software performance study.
- Substantial Equivalence Justification: The entire 510(k) submission aims to prove that the Vathin® Video Bronchoscope System is "substantially equivalent" to existing cleared bronchoscopes. This process typically focuses on demonstrating comparable safety and effectiveness, not necessarily advanced algorithmic performance.
To answer your questions, one would need a 510(k) that specifically addresses an AI/ML-enabled medical device. Such a submission would include detailed performance studies with metrics like sensitivity, specificity, AUC, and often include multi-reader, multi-case (MRMC) studies to demonstrate clinical impact.
If you had provided a 510(k) document for an AI-powered device, the table and answers would look something like this (conceptual example):
Conceptual Example - This section is not based on the provided document as it does not contain the necessary information.
For an AI-powered medical device, the acceptance criteria and study proving its performance would be detailed as follows:
1. Acceptance Criteria and Reported Device Performance
| Metric (for AI-enabled feature, e.g., Nodule Detection) | Acceptance Criteria (e.g., for standalone performance) | Reported Device Performance |
|---|---|---|
| Standalone Performance | ||
| Sensitivity (Recall) | ≥ 90% for nodules > 4mm | 92.5% |
| Specificity | ≥ 80% | 83.1% |
| FROC Score (Free-response ROC) | ≥ 0.85 | 0.87 |
| AI-Assisted Performance (If applicable) | ||
| Reader ROC AUC Improvement | Statistically significant improvement (p |
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(37 days)
Hunan Vathin Medical Instrument Co., Ltd.
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 12Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and four lengths: 35cm, 45cm, 50cm, 55cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
The provided 510(k) clearance letter is for a "Single-Use Ureteral Access Sheath" (K251599), which is a physical medical device and not an AI or software-based device.
Therefore, many of the requested points related to AI/software performance, such as:
- MRMC comparative effectiveness study
- Standalone (algorithm only) performance
- Sample size and ground truth for training set
- Number of experts and their qualifications for ground truth establishment
- Adjudication method for test set
do not apply to this device and its associated performance data.
The performance data provided in the 510(k) summary focuses entirely on non-clinical performance data for a physical device, including:
- Biocompatibility Testing
- Sterility Testing
- Functional and Mechanical Performance Testing (e.g., appearance, size, patency, breaking force, friction, etc.)
Based on the information provided in the 510(k) clearance letter for the Single-Use Ureteral Access Sheath (K251599), here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests conducted but does not explicitly state the quantitative acceptance criteria for each test or the specific numerical results obtained. It generally states that "All evaluation acceptance criteria were met" for biocompatibility and implies successful results for performance testing by concluding substantial equivalence.
| Performance Attribute/Test Category | Acceptance Criteria (Implicit from document) | Reported Device Performance (Implicit from document) |
|---|---|---|
| Biocompatibility | Met ISO 10993-1:2018 recommendations for "breached or compromised surface," "Limited ( |
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(121 days)
Hunan Vathin Medical Instrument Co., Ltd,
The Digital Video Processor is designed to be used with Vathin medical endoscopes, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The Digital Video Processor is used in conjunction with Vathin endoscopes, and other accessories for endoscopic image processing during endoscopic diagnostic and therapeutic procedures. When used, it receives and processes image signals from a digital endoscope and transfers these signals to a connected monitor.
The provided text is a 510(k) Premarket Notification submission for a medical device called "Digital Video Processor" (K243117). It describes the device, its intended use, and compares it to a predicate device (Digital Video Monitor, K231135).
However, the document does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to a study proving the device meets these criteria in the context of an AI/algorithm-based device as requested in the prompt.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This involves comparing features like trade name, classification, product code, regulation number, models, intended use, application field, intended user, max resolution, display type, USB connection, video output, and image/video capture.
- Summary of Non-clinical tests: This section lists general categories of testing performed, such as Electrical safety and electromagnetic compatibility (EMC), Software Verification and Validation Testing, and Performance testing (e.g., Field of view, Depth of field, Geometric distortion, Image intensity uniformity, Color performance).
There is no mention of:
- Specific acceptance criteria with quantitative thresholds.
- Reported device performance data against those thresholds.
- Details of a study involving AI/algorithm performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- How ground truth was established for training sets.
The "Digital Video Processor" appears to be a hardware component for processing endoscopic images, not an AI/algorithm-driven device itself that would require clinical performance studies for diagnostic accuracy. The performance tests listed are related to image quality and system functionality, not diagnostic performance.
Therefore, given the provided text, I cannot fulfill the request for a table of acceptance criteria and the study details as it pertains to an AI/algorithm-based device. The document clears a "Digital Video Processor" as an endoscope accessory, focusing on its functional equivalence, safety, and EMC, not a diagnostic AI tool.
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(114 days)
Hunan Vathin Medical Instrument Co. Ltd
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.
The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.
The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.
Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:
1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:2018 for "Surface - Mucosal Membrane" ( |
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(260 days)
Hunan Vathin Medical Instrument Co., Ltd.
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
The device in question is the Single-use Ureteral Access Sheath (K240167). The provided document is a 510(k) summary, which outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details performance testing for various attributes. While it states "All evaluation acceptance criteria were met" for specific categories (e.g., Biocompatibility), it does not explicitly list numerical or qualitative acceptance criteria for each functional/mechanical test in a table form, nor does it provide the exact reported performance values. It only lists the tests conducted.
| Category | Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1:2018 (no cytotoxicity, no irritation, no sensitization, met pyrogenicity and acute systemic toxicity requirements) | All evaluation acceptance criteria were met. |
| Sterility | Sterile barrier systems met ISO 11607; sterilization process validated per ISO 11135. | Validated in accordance with ISO 11135 and ISO 11607. |
| Functional/Mechanical Performance | Implicitly, met standards for safe and effective use comparable to the predicate device. | All tests listed below were conducted (see section VII for tests listed). The results supported substantial equivalence. |
| - Appearance | (Not explicitly stated, but implies acceptable visual quality) | Conducted |
| - Mark | (Not explicitly stated, but implies clear and correct marking) | Conducted |
| - Size | (Not explicitly stated, but implies dimensional accuracy) | Conducted |
| - Luer fitting | (Not explicitly stated, but implies proper fitting) | Conducted |
| - Patency | (Not explicitly stated, but implies open and unobstructed lumen) | Conducted |
| - Freedom from leakage | (Not explicitly stated, but implies no leaks) | Conducted |
| - Resistance to deformation | (Not explicitly stated, but implies maintaining structural integrity) | Conducted |
| - Breaking force | (Not explicitly stated, but implies adequate strength) | Conducted |
| - Connection firmness | (Not explicitly stated, but implies secure connections) | Conducted |
| - Toughness | (Not explicitly stated, but implies resistance to fracture) | Conducted |
| - Flexural properties | (Not explicitly stated, but implies appropriate flexibility) | Conducted |
| - Anti-twisting force | (Not explicitly stated, but implies resistance to twisting) | Conducted |
| - Compression Resistance | (Not explicitly stated, but implies resistance to compression) | Conducted |
| - Compatibility | (Not explicitly stated, but implies compatibility with other instruments) | Conducted |
| - Air pressure Regulation Function | (Not explicitly stated, but implies proper function) | Conducted |
| - Negative Pressure Suction Function | (Not explicitly stated, but implies proper function) | Conducted |
| - Bending Reliability | (Not explicitly stated, but implies reliable bending without failure) | Conducted |
| - Corrosion resistance | (Not explicitly stated, but implies resistance to corrosion) | Conducted |
| - Friction | (Not explicitly stated, but implies acceptable friction during use) | Conducted |
| - Coating Uniformity | (Not explicitly stated, but implies consistent coating application) | Conducted |
| - Firmness | (Not explicitly stated, but implies appropriate rigidity/stiffness) | Conducted |
| - Chemical Property | (Not explicitly stated, but implies appropriate chemical composition) | Conducted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the non-clinical performance tests (biocompatibility, sterility, functional/mechanical testing).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned for the performance testing. However, the applicant is Hunan Vathin Medical Instrument Co., Ltd., located in China, suggesting the testing was likely conducted by or for the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical instrument (Ureteral Access Sheath), not an AI/Software as a Medical Device (SaMD) that requires expert consensus for ground truth establishment. Therefore, this information is not applicable. The "ground truth" for this device is based on objective measurements and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this is not a clinical study involving human interpretation or subjective assessment necessitating adjudication, this information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted. This device is a physical medical instrument and does not involve AI assistance or human reader interpretation in its intended use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI/software performance. This device is a physical medical instrument, so this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this device's performance evaluation is based on objective measurements and tests against established engineering, material, and biocompatibility standards. For example:
- Biocompatibility: In vitro and in vivo tests according to ISO 10993-1, measured against scientific criteria (e.g., cell viability for cytotoxicity, skin reaction for irritation).
- Sterility: Measured by sterility assurance level (SAL) achieved through validated sterilization processes per ISO 11135.
- Functional/Mechanical: Measured by physical properties (e.g., dimensions, force resistance, patency, leakage) against pre-defined specifications derived from engineering principles and comparison to the predicate device.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning or AI. It is a physical medical device.
9. How the ground truth for the training set was established
As there is no training set for this physical device, this question is not applicable.
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(136 days)
Hunan Vathin Medical Instrument Co., Ltd.
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(271 days)
Hunan Vathin Medical Instrument Co., Ltd.
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Video Ureteroscope System consists of Single-use Flexible Ureteroscope (Model:US-S2600, US-E2600) and Digital Video Monitor(Model:DVM-B1) . During diagnosis and treatment with the Video Ureteroscope System, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.
I am sorry, but the provided text from the FDA 510(k) notification for the "Video Ureteroscope System" does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device.
The document primarily focuses on:
- Substantial equivalence to a predicate device (another ureteroscope system).
- Device description (components, how it works).
- Indications for use.
- Comparison of technological characteristics with the predicate device.
- Summary of non-clinical tests (biocompatibility, sterility, electrical safety, EMC, and general performance testing).
There is no mention of an AI or Machine Learning component in the device. Therefore, the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML system.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for AI/ML ground truth.
- MRMC comparative effectiveness study results for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth for an AI system.
- Sample size for an AI training set.
- Ground truth establishment for an AI training set.
cannot be extracted from this document.
The document states that "Performance testing was conducted on the Video Ureteroscope System." (page 8), but it does not detail what specific performance tests were conducted, what the acceptance criteria were for those tests, or the results, beyond a general statement that "The non-clinical testing demonstrates that the device is as effective and performs as well as the legally marketed device." This general statement refers to the functional performance of the ureteroscope system itself (e.g., image quality, bending angle, working length, irrigation, etc.) compared to its predicate, not the performance of an AI algorithm.
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(107 days)
Hunan Vathin Medical Instrument Co., Ltd.
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.
The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.
The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.
The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user .
- Flexible insertion cord .
- Camera and LED light source at the distal tip .
- . Sterilized by Ethylene Oxide
- For single use
The differences between the Single-use flexible Rhinolaryngoscope models are as follow:
- . Have or haven't working channel
- . Working channel inner diameter
- . Insertion tube outer diameter
- . The length of insertion tube
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information:
Device: Vathin® Video Rhinolaryngoscope System (includes Single-use Flexible Rhinolaryngoscope and Digital Video Monitor)
1. A table of acceptance criteria and the reported device performance
The provided document describes the device's technical specifications and reports that all evaluation acceptance criteria were met for the non-clinical tests. However, it does not explicitly state numerical acceptance criteria for each performance parameter, nor does it provide a direct comparison table of "acceptance criteria vs. reported performance" in a quantitative manner. Instead, it lists the tests performed and implies compliance.
Below is a table summarizing the reported device performance characteristics where numerical values are given, and notes where general compliance is stated without specific numerical acceptance criteria.
| Feature | Reported Device Performance | Acceptance Criteria (Implied / Stated) |
|---|---|---|
| Rhinolaryngoscope | ||
| Field of View (degree) | 110° | Not explicitly stated, but "larger (than predicate) is beneficial" |
| Direction of View (degree) | 0° | Not explicitly stated |
| Bending Angle (degree) | Up: 210°, Down: 210° | Not explicitly stated, but "larger (than predicate) means more flexibility" |
| Max Insertion Portion Width (mm) | RL-S1800, etc.: 3.2; RL-S1E00, etc.: 5.0 | Not explicitly stated, but "smaller (than predicate) for easier patient entry" |
| Min Insertion Channel Width (mm) | RL-S1800, etc.: 0; RL-S1E00, etc.: 2.2 | Not explicitly stated, but "larger (than predicate) is more convenient for doctors" |
| Working Length (mm) | 300 | "Meets the needs of clinical use," considered substantially equivalent to predicate's 350mm |
| Illumination Source | LED | Same as predicate |
| Single-Use | Yes | Same as predicate |
| Biocompatibility | No Cytotoxicity, No Irritation to Skin, No significant evidence of sensitization, No pyrogen | All evaluation acceptance criteria were met (based on ISO 10993-1) |
| Sterilization | EO | Same as predicate |
| Digital Video Monitor | ||
| Max. Resolution | 1280 x 800 | Not explicitly stated, but higher than reference device's 800x480 |
| Display Type | 12.1" touch screen | Not explicitly stated, but different from reference device's 8.5" colour TFT LCD |
| USB Connection | A-type | Same as reference device |
| Video Output | HDMI/USB 2.0 | Different from reference device's RCA connection |
| Image/Video Capture | Yes | Same as reference device |
| Electrical Safety / EMC | System complies with standards | IEC 60601-1, IEC60601-2-18 for safety; IEC 60601-1-2 for EMC |
| Other Performance Tests | All "evaluation acceptance criteria were met" | (Tests listed in Section VII: Appearance, dimensions and weight, Functional performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document comprehensively lists various non-clinical tests conducted (Biocompatibility, Electrical Safety/EMC, Performance testing including Appearance, Dimensions, Weight, and Functional Performance). However, it does not specify the sample size used for any of these test sets, nor does it provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were non-clinical, bench-top tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document describes non-clinical, bench-top testing. For such tests, the "ground truth" is typically established by industry standards, engineering specifications, and validated measurement methods, rather than by human expert consensus or qualifications in the medical sense for diagnostic performance. Therefore, no information on the number or qualifications of experts for establishing ground truth is provided or relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the study described involves non-clinical engineering and performance testing, rather than human interpretation of medical data, the concept of an "adjudication method" (like 2+1 or 3+1 for resolving discrepancies in expert interpretations) is not applicable and not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned or performed. This submission is for a medical device (endoscope system) and not an AI-powered diagnostic tool. The focus is on the substantial equivalence of the hardware's performance and safety.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or performed. This device is a physical Rhinolaryngoscope and Digital Video Monitor, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests conducted:
- Biocompatibility: Ground truth was established by adherence to ISO 10993-1:2018 standards and validated laboratory tests (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity).
- Electrical Safety and Electromagnetic Compatibility (EMC): Ground truth was established by compliance with international standards (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2).
- Performance Testing (Appearance, Dimensions, Weight, Functional Performance): Ground truth was established by engineering specifications and validated measurement methods as defined in the test protocols (e.g., measuring angles, lengths, diameters, image quality parameters).
8. The sample size for the training set
Not applicable. This submission describes a hardware medical device, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
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(113 days)
Hunan Vathin Medical Instrument Co., Ltd.
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. The compatible Digital Video Monitor: Model: DVM-A1. The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same. The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.
The provided text describes the regulatory filing for a medical device (Single-use Flexible Ureteroscope) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to its performance in a clinical setting or its impact on human readers, especially regarding AI assistance. The document focuses on physical, optical, electrical and biocompatibility performance.
Therefore, I cannot provide the requested information about acceptance criteria for clinical performance or studies involving human readers/AI assistance based on the text.
However, I can extract information regarding the non-clinical performance acceptance criteria and proof as described in the document.
Here's an interpretation based on the provided text, focusing on the available non-clinical performance and acceptance testing:
Device: Single-use Flexible Ureteroscope
Study Type: Non-clinical Performance Testing and Biocompatibility Testing (for 510(k) Substantial Equivalence)
1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:
The document mentions that "All evaluation acceptance criteria were met" for biocompatibility and that the device "complies with" relevant electrical safety and EMC standards. For functional, mechanical, and optical performance, it lists the tests performed, implying that the device passed these tests to demonstrate equivalence. Specific quantitative acceptance values are not explicitly stated for all tests, but compliance with standards and successful completion of tests serve as the "proof."
| Category | Test Performed | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | No Cytotoxicity (as per ISO 10993-1:2018) | Met acceptance criteria |
| Irritation | No Irritation to Skin (as per ISO 10993-1:2018) | Met acceptance criteria | |
| Sensitization | No significant evidence of sensitization (as per ISO 10993-1:2018) | Met acceptance criteria | |
| Pyrogenicity | (Not explicitly stated for acceptance, but implied by ISO) | Met acceptance criteria | |
| Acute Systemic Toxicity | (Not explicitly stated for acceptance, but implied by ISO) | Met acceptance criteria | |
| Sterility | Sterile barrier systems evaluation | Compliance with ISO 11607 | Complies |
| Sterilization process validation | Compliance with ISO 11135 | Validated | |
| Electrical Safety | Electrical safety testing | Compliance with IEC 60601-1 and IEC 60601-2-18 | Complies |
| Electromagnetic | EMC testing | Compliance with IEC 60601-1-2 | Complies |
| Functional Performance | Appearance, Working length, Work channel ID, Head OD, Outer diameter of main hose, Max outer diameter of insertion part, Bending angle, Product weight, Rotating sleeve, Handle-based photographing function, Self-locking function, Wire length, Image display, Waterproofness, Lens fogging, Image quality, LED illuminance test, LED color temperature test, Air tightness test, Suction ability, Water delivery ability, LED temperature test | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
| Mechanical Performance | Handle-based camera button reliability, Passively bent part reliability, Self-locking component reliability, Insertion end tension, Pull out tension of plug end | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
| Optical Performance | Direction of view, Field of view, Observation depth of field, Geometric distortion, SNR, Dynamic tolerance, Brightness uniformity | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
| Color Performance | Color restoration test | Met design specifications and intended performance | Passed/Met (Implied by conclusion of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test. These are non-clinical (bench) tests, so the "sample size" would refer to the number of device units tested. This might range from a few units to a statistically significant number depending on the specific test and standard, but the document does not specify.
- Data Provenance: The tests were conducted internally by the manufacturer (Hunan Vathin Medical Instrument Co., Ltd.) or by accredited labs on their behalf, likely in China given the company's location. This is inherently retrospective data gathered for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This section typically applies to studies where human interpretation of medical images or clinical data is involved. Since this document describes non-clinical, bench testing, no human experts were used to establish a "ground truth" in the clinical sense. The "ground truth" for these tests are the objective measurements against engineering specifications and international standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As no human interpretation and subsequent need for consensus are involved in these non-clinical tests, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe any MRMC study. There is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:
- No. This device is an endoscope, not an AI algorithm. Therefore, "standalone" AI performance is not applicable. The performance described is the inherent performance of the optical, mechanical, and electrical components of the device itself.
7. Type of Ground Truth Used:
- For Biocompatibility, Electrical Safety, EMC, and Sterility: Adherence to International Standards (e.g., ISO 10993, ISO 11607, ISO 11135, IEC 60601 series) and Regulatory Requirements.
- For Functional, Mechanical, and Optical Performance: Engineering Specifications and Design Requirements agreed upon during device development.
8. Sample Size for the Training Set:
- Not Applicable. This device is a physical instrument, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set is involved.
In summary, the provided FDA clearence letter and supporting summary pertains to the substantial equivalence of a physical medical device (endoscope) based on its non-clinical performance and safety characteristics, not on the performance of a diagnostic AI algorithm or its impact on human readers.
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Hunan Vathin Medical Instrument Co., Ltd.
The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Vathin® Video Bronchoscope System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a standard FDA clearance document that states the device has been found substantially equivalent to a legally marketed predicate device. It discusses regulatory aspects, such as general controls, potential additional controls for Class II/III devices, and compliance with various FDA regulations.
It does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology).
- How ground truth for any set was established.
Therefore, I cannot fulfill your request for this information based on the provided text. To obtain such details, you would typically need to refer to scientific publications, clinical trial reports, or other technical documentation directly submitted to the FDA, which are not part of this clearance letter.
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